Hemophilia ANCT02634723
Retrospective Chart Review to Evaluate Safety and Tolerability of ADVATE Among Previously Untreated Patients in China With Moderate to Severe Hemophilia A
An observational study of Hemophilia A, run by Baxalta now part of Shire at 6 sites in China.
Trial summary
The purpose of this post-marketing safety study is to evaluate the safety, immunogenicity, and effectiveness of ADVATE in previously untreated patients (PUPs) in China with moderate to severe hemophilia A. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hemophilia A
- What is being tested?
- Octocog alfa (recombinant human coagulation factor VIII)
- How many people
- 21 participants
- Where
- 6 sitesChina
- Study dates
- 23 Dec 2015to 30 Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Previously untreated patients (PUPs) in China with moderate to severe hemophilia A.
Who may be able to join
- Previously untreated patient (PUP) in China with moderate to severe hemophilia A.
- Investigator prescribed ADVATE as the predominant therapeutic agent for the management of hemophilia A
- Informed consent form from patient and/or legal representative will need to be signed per local regulation
Who cannot join
- Presence of an inherited or acquired hemostatic defect other than hemophilia A, and any other clinically significant chronic disease
- Participants who participated in another investigational FVIII drug study, or had participated in any clinical study involving an investigational FVIII drug during the course of the observation period
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
Zhejiang Provincial Hospital of TCM/The First Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang, 310006
Institute of Hematology and Oncology, Harbin The First Hospital
Harbin, Heilongjiang, 150070
Shandong Blood Center
Jinan, Shandong, 250014
Nanjing Children's Hospital Affiliated to Nanjing Medical University
Nanjing, Jiangsu, 210019
Tongji Hospital, Tongji Medical College of Huazhong University of Science & Technology
Wuhan, Hubei, 430074
Henan Provincial People's Hospital
Zhengzhou, Henan, 450000
About this study
The purpose of this post-marketing safety study is to evaluate the safety, immunogenicity, and effectiveness of ADVATE in previously untreated patients (PUPs) in China with moderate to severe hemophilia A.
- Conditions
- Hemophilia A
- Being tested
- Octocog alfa (recombinant human coagulation factor VIII)
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Octocog alfa (recombinant human coagulation factor VIII)Biological
Also called ADVATE, Recombinant antihemophilic factor, plasma/albumin-free method (rAHF-PFM
| Study group | Role | What they receive |
|---|---|---|
| Previously Untreated Patients (PUPs) | PUPs in China with Moderate to Severe Hemophilia A Receives: Biological: Octocog alfa (recombinant human coagulation factor VIII) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of high titer, low titer and transient Factor VIII (FVIII) inhibitors developed
Measured: Throughout the study period of 6 months
Number and type of other serious and non-serious adverse events (AEs)
Other AEs refers to AEs other than Factor VIII (FVIII) inhibitors
Measured: Throughout the study period of 6 months
Secondary outcomes (8)
Number and type of bleeding episodes treated with ADVATE
Measured: Throughout the study period of 6 months
Number of bleeding episodes treated with 1, 2, 3, ≥ 4 infusions of ADVATE
Measured: Throughout the study period of 6 months
Annualized bleeding rate (ABR) of participants treated prophylactically and on-demand with ADVATE
Measured: Throughout the study period of 6 months
Annualized joint bleeding rate (AJBR) of participants treated prophylactically and on-demand with ADVATE
Measured: Throughout the study period of 6 months
Total number of exposure days (EDs) to ADVATE
Measured: Throughout the study period of 6 months
Total units of ADVATE administered
Measured: Throughout the study period of 6 months
Total number of exposure days (EDs) to all Factor VIII (FVIII) products
Measured: Throughout the study period of 6 months
Total units of all Factor VIII (FVIII) products administered
Measured: Throughout the study period of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2015 (estimated)
- Study start23 Dec 2015
- Primary completion30 Jun 2016
- Study completion30 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemophilia AStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baxalta now part of Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02634723
- Sponsor's protocol ID
- 061501
- Status last verified
- Mar 2021
- First submitted
- 16 Dec 2015
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Chart Review to Evaluate Safety and Tolerability of ADVATE Among Previously Untreated Patients in China With Moderate to Severe Hemophilia A
- ClinicalTrials.gov ID
- NCT02634723
- Acronym / sponsor ID
- 061501
- Conditions
- Hemophilia A
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Baxalta now part of ShireIndustry (pharma, biotech, devices)
- Study start
- 23 Dec 2015 (actual)
- Primary completion
- 30 Jun 2016 (actual)
- Study completion
- 30 Jun 2016 (actual)
- First posted
- 18 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this post-marketing safety study is to evaluate the safety, immunogenicity, and effectiveness of ADVATE in previously untreated patients (PUPs) in China with moderate to severe hemophilia A.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Previously Untreated Patients (PUPs) | – | Biological: Octocog alfa (recombinant human coagulation factor VIII)PUPs in China with Moderate to Severe Hemophilia A |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Previously untreated patients (PUPs) in China with moderate to severe hemophilia A.
Key inclusion criteria (3 listed)
- Previously untreated patient (PUP) in China with moderate to severe hemophilia A.
- Investigator prescribed ADVATE as the predominant therapeutic agent for the management of hemophilia A
- Informed consent form from patient and/or legal representative will need to be signed per local regulation
Key exclusion criteria (2 listed)
- Presence of an inherited or acquired hemostatic defect other than hemophilia A, and any other clinically significant chronic disease
- Participants who participated in another investigational FVIII drug study, or had participated in any clinical study involving an investigational FVIII drug during the course of the observation period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Octocog alfa (recombinant human coagulation factor VIII)Also: ADVATE, Recombinant antihemophilic factor, plasma/albumin-free method (rAHF-PFM | Biological | Previously Untreated Patients (PUPs) |
Primary outcome
Number of high titer, low titer and transient Factor VIII (FVIII) inhibitors developed
Time frame: Throughout the study period of 6 months
Number and type of other serious and non-serious adverse events (AEs)
Time frame: Throughout the study period of 6 months
Other AEs refers to AEs other than Factor VIII (FVIII) inhibitors
8 secondary outcomes
Number and type of bleeding episodes treated with ADVATE
Time frame: Throughout the study period of 6 months
Number of bleeding episodes treated with 1, 2, 3, ≥ 4 infusions of ADVATE
Time frame: Throughout the study period of 6 months
Annualized bleeding rate (ABR) of participants treated prophylactically and on-demand with ADVATE
Time frame: Throughout the study period of 6 months
Annualized joint bleeding rate (AJBR) of participants treated prophylactically and on-demand with ADVATE
Time frame: Throughout the study period of 6 months
Total number of exposure days (EDs) to ADVATE
Time frame: Throughout the study period of 6 months
Total units of ADVATE administered
Time frame: Throughout the study period of 6 months
Total number of exposure days (EDs) to all Factor VIII (FVIII) products
Time frame: Throughout the study period of 6 months
Total units of all Factor VIII (FVIII) products administered
Time frame: Throughout the study period of 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
- To obtain more information on the study, click here/on this link.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemophilia A, run by Baxalta now part of Shire at 6 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of high titer, low titer and transient Factor VIII (FVIII) inhibitors developed (time frame: Throughout the study period of 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2021.